bioAffinity Technologies (BIAF) Status Update summary

Business performance and growth

• Achieved record sales for CyPath Lung in 2024, with over 1,700% increase in sales through November 30 compared to the prior year.

• Precision Pathology Services, the wholly-owned subsidiary, is on track for $9.4 million in 2024 revenue, reflecting over 20% annualized growth post-acquisition.

• CyPath Lung revenues expected to reach $600,000 in 2024.

• Gross margins improved to 38.7% in Q3 2024, driven by high-margin CyPath Lung test.

• Operations cash use reported at $600,000 per month, with $2 million cash on hand as of November 12, 2024.

Market expansion and strategy

• Initial launch focused on Texas, now expanding nationally, targeting VA, military, and strategic private/academic markets.

• Added to the Federal Supply Schedule, enabling access to over 1,300 healthcare facilities for the U.S. military and VA.

• Physician adoption grew 40% quarter over quarter, from 100 to 140 offices, with word-of-mouth driving expansion.

• Marketing efforts to intensify in 2025, including hiring a marketing director and partnering with a new agency.

• Infrastructure can handle thousands of tests, supporting anticipated growth.

Product development and clinical progress

• CyPath Lung is a non-invasive, AI-enhanced test for early lung cancer detection, showing 92% sensitivity and 87% specificity.

• Clinical trial published in Respiratory Research included 150 patients.

• Pivotal FDA clinical trial for CyPath Lung to begin in 2025, expected to last three years, with broad participation from VA and military hospitals.

• CyPath Lung is currently a laboratory-developed test, grandfathered under new FDA rules, and will continue to be marketed during the FDA process.

• Research pipeline includes tests for COPD and asthma, aiming to expand addressable market.